Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00666861




Registration number
NCT00666861
Ethics application status
Date submitted
23/04/2008
Date registered
25/04/2008
Date last updated
30/07/2009

Titles & IDs
Public title
Type 2 Diabetes and Exercise - A Pilot Study
Scientific title
Understanding the Acute Effects of Prolonged Sedentary Behaviour (Sitting) on Post-meal Glucose and Lipids - A Pilot Study
Secondary ID [1] 0 0
290/07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
1. Diet controlled Diabetes
2. Overweight (BMI > 27 kg/m2 but <50 kg/m2)
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Hypoglycaemic Agents
2. Lipid Lowering Agents

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
International Diabetes Institute, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Baker Heart Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A randomised, cross-over trial targeting a small sample of older (age 45-65 years) overweight adults with type 2 diabetes the aims of this pilot study are to:

1. Determine the feasibility of investigating the acute effects of prolonged sedentary behaviour (sitting) in this target group.
2. Compare the acute effects of a single prolonged (8 hour) bout of sedentary behaviour (sitting) on glucose and triglyceride concentrations and key muscle and adipose regulatory enzymes to a similar bout of sedentary behaviour combined with intermittent bouts of light-intensity activity.
Trial website
https://clinicaltrials.gov/study/NCT00666861
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bronwyn A Kingwell, PhD
Address 0 0
Baker Heart Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00666861